Active Ingredient: Fidanacogene elaparvovec
Fidanacogene elaparvovec is indicated for the treatment of severe and moderately severe haemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 500,000,000,000 copies fidanacogene elaparvovec, one dose.
Eligibility for treatment should be confirmed within 8 weeks prior to infusion by the following test results:
The recommended dose of fidanacogene elaparvovec is a single-dose of 5 × 1011 vector genomes per kg (vg/kg) of body weight.
To determine the patient’s dose, the following calculation steps are needed:
Calculation of patient’s dose weight:
The dose of fidanacogene elaparvovec is based on the patient’s body mass index (BMI) in kg/m².
Table 1. Patient’s dose weight adjustment according to BMI:
| Patient’s BMI | Patient’s dose weight (kg) adjustment |
|---|---|
| ≤30 kg/m² | Dose weight = Actual body weight |
| >30 kg/m² | Determine using the following calculation: Dose weight (kg) = 30 kg/m² × [Height (m)]2 |
Note:
Calculation of patient’s dose volume in millilitres (mL):
Patient’s dose weight in kilograms (kg) × target dose per kilogram (5 × 1011 vg/kg) = dose in vg to be administered
Dose in vg to be administered ÷ Actual concentration (vg/mL)* = patient’s dose volume in mL
* See the accompanying LIS for information pertaining to the actual concentration of vg per vial.
Fidanacogene elaparvovec is administered as a single-dose intravenous infusion over approximately 60 minutes in an appropriate infusion volume.
Do not infuse as an intravenous push or bolus. In the event of an infusion reaction during administration, the infusion rate should be slowed or stopped to ensure patient tolerability. If the infusion is stopped, it may be restarted at a slower rate when the infusion reaction is resolved.
Before administration, it must be confirmed that the patient’s identity matches the unique patient information (i.e., lot number) on the vials, inner cartons, outer cartons, and accompanying documentation. The total number of vials to be administered must also be confirmed with the patient-specific information on the LIS.
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